Trial · NCT01839487
PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer
NCT01839487, Phase 2, Completed, Halozyme Therapeutics; results first posted 2020-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer. Trials, record NCT01839487. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01839487
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer
- NCT number
- NCT01839487
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 279 participants, actual
- Lead sponsor
- Halozyme Therapeutics
- Conditions
- Metastatic Pancreatic Cancer
- Interventions
- PEGPH20, Nab-paclitaxel, Gemcitabine, Dexamethasone, Enoxaparin
- First posted
- 2013-04-25
- Last updated
- 2020-07-20
- Results first posted
- 2020-07-20
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | From the date of randomization until disease progression or death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG) | PFS: time from randomization until first occurrence of disease progression, either by central radiologic determination (Response Evaluation Criteria in Solid Tumours \[RECIST\] version 1.1) or by clinical progression determined by Investigator, or death during treatment period from any cause. Radiological disease progression was defined as at least a 20 percent (%) increase in sum of diameters of target lesions, taking as reference the smallest sum on study thus far, nadir (this included baseline sum if that was the smallest on study); Sum must also demonstrate an absolute increase of at least 5 millimeters (mm); Appearance of one or more new lesions; Unequivocal progression of existing non-target lesions. Surviving participants without disease progression were censored for PFS analysis at the date of last evaluable post-baseline tumor assessment. Surviving participants without any post-baseline disease assessment were censored on Day 1. PFS was estimated using Kaplan-Meier (KM) method. |
| Primary | Percentage of Participants in the PAG Arm Who Experienced Any Thromboembolic (TE) Event in Stage 2 of the Study | From first exposure to any study drug (PEGPH20, NAB, GEM) through 30 days after end of treatment visit (maximum exposure: 30.72 months for PAG) | TE events were identified by applying the Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Queries (SMQ) search strategy for 3 SMQs: TE arterial, TE venous, and TE vessel type unspecified and mixed arterial and venous. TE events were considered by the Sponsor to be adverse events (AEs) of special interest. All TE events, regardless of type of event, severity, or seriousness were reported. Participants with multiple events were counted only once. A summary of serious and all other non-serious adverse events regardless of causality is located in the 'Reported AE section'. |
| Secondary | PFS in Relation to Tumor Hyaluronan (HA) Levels | From the date of randomization until disease progression or death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG) | PFS was defined as time from randomization until first occurrence of disease progression, either by central radiologic determination (RECIST version 1.1) or by clinical progression determined by Investigator, or death during treatment period from any cause. Disease progression was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study thus far, nadir (this included baseline sum if that was the smallest on study); Sum must also demonstrate an absolute increase of at least 5 mm; Appearance of one or more new lesions; Unequivocal progression of existing non-target lesions. Surviving participants without disease progression were censored for PFS analysis at the date of last evaluable post-baseline tumor assessment. Surviving participants without any post-baseline disease assessment were censored on Day 1. PFS was estimated using KM method. PFS was measured in HA-high and HA-low participants. |
| Secondary | Objective Response Rate (ORR): Percentage of Participants With Objective Response | From the date of randomization until last date on study treatment (maximum exposure: 30.72 months for PAG, and 20.27 months for AG) | ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR) regardless of confirmation, as assessed by RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Overall Survival | From randomization until death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG) | Overall survival was defined as the time from randomization until death from any cause. Participants who died or were lost to follow-up by the date of analysis data cutoff were censored at their last contact date. |
| Secondary | Percentage of Participants With AEs | From first exposure to any study drug (PEGPH20, NAB, GEM) through 30 days after end of treatment visit (maximum exposure: 30.72 months for PAG and 20.27 months for AG) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of PEGPH20 | Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1 | Samples were analyzed for PEGPH20 concentration using a validated electrochemiluminescence immunoassay. Plasma samples to assess the potential effects of NAB+GEM on PEGH20 pharmacokinetic (PK) were collected in the PAG treatment group in the run-in phases (Run-in Phase 1: Original PEGPH20 formulation \[3.5 mg/mL\], and Run-in Phase 2: New PEGPH20 formulation \[0.3 mg/mL\]). |
| Secondary | Time to Reach Cmax (Tmax) of PEGPH20 | Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1 | Samples were analyzed for PEGPH20 concentration using a validated electrochemiluminescence immunoassay. Plasma samples to assess the potential effects of NAB+GEM on PEGH20 PK were collected in the PAG treatment group in the run-in phases (Run-in Phase 1: Original PEGPH20 formulation \[3.5 mg/mL\], and Run-in Phase 2: New PEGPH20 formulation \[0.3 mg/mL\]). |
| Secondary | Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of PEGPH20 | Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1 | Samples were analyzed for PEGPH20 concentration using a validated electrochemiluminescence immunoassay. Plasma samples to assess the potential effects of NAB+GEM on PEGH20 PK were collected in the PAG treatment group in the run-in phases (Run-in Phase 1: Original PEGPH20 formulation \[3.5 mg/mL\], and Run-in Phase 2: New PEGPH20 formulation \[0.3 mg/mL\]). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) | From the date of randomization until disease progression or death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG) | Efficacy evaluable (EE) population: all randomized participants who received at least 1 dose of any study drug, who had measurable disease at baseline, and had a post-baseline response assessment, or had clinical disease progression without a post-baseline computed tomography (CT) scan, or had died on or prior to 14 days after the last dose date. | months | MEDIAN |
| PRIMARY | Percentage of Participants in the PAG Arm Who Experienced Any Thromboembolic (TE) Event in Stage 2 of the Study | From first exposure to any study drug (PEGPH20, NAB, GEM) through 30 days after end of treatment visit (maximum exposure: 30.72 months for PAG) | Safety population of Stage 2 included all participants enrolled in Stage 2 of Phase 2 of study after the clinical hold, and who received at least 1 dose of study drug. This outcome was planned to be reported only for PAG arm as pre-specified in protocol. | percentage of participants | NUMBER |
| SECONDARY | PFS in Relation to Tumor Hyaluronan (HA) Levels | From the date of randomization until disease progression or death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG) | Intent-to -treat (ITT) population included all participants who were randomized, including the run-in phases. 'Number analyzed'=participants with HA-high or HA-low levels. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR): Percentage of Participants With Objective Response | From the date of randomization until last date on study treatment (maximum exposure: 30.72 months for PAG, and 20.27 months for AG) | ITT population included all participants who were randomized, including the run-in phases. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | From randomization until death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG) | ITT population included all participants who were randomized, including the run-in phases. | months | MEDIAN |
| SECONDARY | Percentage of Participants With AEs | From first exposure to any study drug (PEGPH20, NAB, GEM) through 30 days after end of treatment visit (maximum exposure: 30.72 months for PAG and 20.27 months for AG) | Safety population included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of PEGPH20 | Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1 | PK analysis population included all participants who received any part of a dose of PEGPH20 and had measurable PEGPH20 concentrations in at least 1 sample collected for PK analysis. 'Number analyzed'=participants evaluable for this outcome at specified timepoints. | nanograms/milliliter (ng/mL) | MEAN |
| SECONDARY | Time to Reach Cmax (Tmax) of PEGPH20 | Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1 | PK analysis population included all participants who received any part of a dose of PEGPH20 and had measurable PEGPH20 concentrations in at least 1 sample collected for PK analysis. 'Number analyzed'=participants evaluable for this outcome at specified timepoints. | hours | MEDIAN |
| SECONDARY | Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of PEGPH20 | Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1 | PK analysis population included all participants who received any part of a dose of PEGPH20 and had measurable PEGPH20 concentrations in at least 1 sample collected for PK analysis. 'Number analyzed'=participants evaluable for this outcome at specified timepoints. | hours*ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | 6.05 | 95% Confidence Interval 5.36 to 7.20 | months | |
| Progression-Free Survival (PFS) | AG: Nab-paclitaxel + Gemcitabine | 5.26 | 95% Confidence Interval 3.91 to 6.54 | months | |
| Percentage of Participants in the PAG Arm Who Experienced Any Thromboembolic (TE) Event in Stage 2 of the Study | PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | 14.0 | percentage of participants | ||
| PFS in Relation to Tumor Hyaluronan (HA) Levels | PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | HA-High | 9.23 | 95% Confidence Interval 5.98 to 10.55 | months |
| PFS in Relation to Tumor Hyaluronan (HA) Levels | AG: Nab-paclitaxel + Gemcitabine | HA-High | 5.19 | 95% Confidence Interval 3.52 to 6.54 | months |
| PFS in Relation to Tumor Hyaluronan (HA) Levels | PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | HA-Low | 5.59 | 95% Confidence Interval 4.70 to 7.03 | months |
| PFS in Relation to Tumor Hyaluronan (HA) Levels | AG: Nab-paclitaxel + Gemcitabine | HA-Low | 5.26 | 95% Confidence Interval 3.78 to 7.33 | months |
| Objective Response Rate (ORR): Percentage of Participants With Objective Response | PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | 40.4 | 95% Confidence Interval 32.83 to 48.24 | percentage of participants | |
| Objective Response Rate (ORR): Percentage of Participants With Objective Response | AG: Nab-paclitaxel + Gemcitabine | 32.7 | 95% Confidence Interval 24.21 to 42.21 | percentage of participants | |
| Overall Survival | PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | 9.59 | 95% Confidence Interval 8.15 to 12.06 | months |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-in Phase (Maximum Exposure:295 Days) | STARTED | Run-in Phase - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | 16 | |
| Run-in Phase (Maximum Exposure:295 Days) | STARTED | Run-in Phase - AG: Nab-paclitaxel + Gemcitabine | 7 | |
| Run-in Phase (Maximum Exposure:295 Days) | STARTED | Phase 2: Stage 1 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | 0 | |
| Run-in Phase (Maximum Exposure:295 Days) | STARTED | Phase 2: Stage 1 - AG: Nab-paclitaxel + Gemcitabine | 0 | |
| Run-in Phase (Maximum Exposure:295 Days) | STARTED | Phase 2: Stage 2 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | 0 | |
| Run-in Phase (Maximum Exposure:295 Days) | STARTED | Phase 2: Stage 2 - AG: Nab-paclitaxel + Gemcitabine | 0 | |
| Run-in Phase (Maximum Exposure:295 Days) | COMPLETED | Run-in Phase - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | 0 | |
| Run-in Phase (Maximum Exposure:295 Days) | COMPLETED | Run-in Phase - AG: Nab-paclitaxel + Gemcitabine | 0 | |
| Run-in Phase (Maximum Exposure:295 Days) | COMPLETED | Phase 2: Stage 1 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | 0 | |
| Run-in Phase (Maximum Exposure:295 Days) | COMPLETED | Phase 2: Stage 1 - AG: Nab-paclitaxel + Gemcitabine | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events504
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | 63 | 160 | |
| other | Anaemia | Blood and lymphatic system disorders | AG: Nab-paclitaxel + Gemcitabine | 41 | 100 | |
| other | Leukopenia | Blood and lymphatic system disorders | PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | 15 | 160 | |
| other | Leukopenia | Blood and lymphatic system disorders | AG: Nab-paclitaxel + Gemcitabine | 7 | 100 | |
| other | Lymphopenia | Blood and lymphatic system disorders | PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | 8 | 160 | |
| other | Lymphopenia | Blood and lymphatic system disorders | AG: Nab-paclitaxel + Gemcitabine | 5 | 100 | |
| other | Neutropenia | Blood and lymphatic system disorders | PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | 53 | 160 | |
| other | Neutropenia | Blood and lymphatic system disorders | AG: Nab-paclitaxel + Gemcitabine | 18 | 100 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | 41 | 160 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | AG: Nab-paclitaxel + Gemcitabine | 17 | 100 |
1 to 10 of 504Source ClinicalTrials.gov
See all 504 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | 131 | 166 |
| Total, all-cause mortality | AG: Nab-paclitaxel + Gemcitabine | 87 | 113 |
| Total, other adverse events | PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | 157 | 160 |
| Total, other adverse events | AG: Nab-paclitaxel + Gemcitabine | 98 | 100 |
| Total, serious adverse events | PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | 101 | 160 |
| Total, serious adverse events | AG: Nab-paclitaxel + Gemcitabine | 58 | 100 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine vs AG: Nab-paclitaxel + Gemcitabine: deaths from any cause | Trial comparisons |
| PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine vs AG: Nab-paclitaxel + Gemcitabine: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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